Clinical Research Project Manager C

Department of Medicine Clinical Trials Unit (DOM CTU) • Perelman School of Medicine • Philadelphia, Pennsylvania

About the role

The Regulatory/Project Manager C provides regulatory expertise and oversight, project management, and staff supervision for the Department of Medicine Clinical Trials Unit (DOM CTU). The position supports phase I–IV, investigator-initiated, and industry-sponsored research across disease areas and levels of complexity, combining hands-on study management with senior-level consultation and leadership of complex projects when assigned. The manager independently prepares and oversees regulatory submissions, documentation, and approvals; serves as a senior regulatory resource; advises on regulatory approaches; and resolves complex compliance issues. Additional responsibilities include securing funded work for this position, pursuing work for other DOM CTU staff to support unit-wide sustainability, and coordinating routine unit administration.

Responsibilities

• Independently prepare and oversee regulatory submissions, documentation, and approvals; serve as a senior regulatory resource; advise on regulatory approaches; and resolve complex compliance issues
• Manage audit/inspection preparation and responses, corrective actions, regulatory SOPs and quality-review processes, and IND/IDE exemption assessments and submissions when included in assigned services
• Lead study intake, feasibility, start-up, implementation, and close-out; develop project plans and study tools; contribute to protocol and grant development, budgets, and resource planning
• Lead project teams, resolve operational barriers, develop performance metrics, and monitor study quality, recruitment, scope, budgets, and deliverables
• Advise on resource deployment and implement improvements across assigned projects
• Directly supervise assigned research staff, including work assignment, workload and quality monitoring, onboarding, training, coaching, and performance evaluation
• Participate in recruitment, address performance and development needs, and promote consistent use of SOPs, study tools, and best practices across assigned teams
• Proactively market DOM CTU staff and services; take primary responsibility for securing funded work to sustain this position; share responsibility for pursuing and securing assignments for other CTU staff to support unit-wide financial sustainability
• Coordinate routine unit administration, performing or delegating tasks while remaining accountable for timely completion

Qualifications

Required

• Master's degree and 5–7 years of related clinical research experience, or an equivalent combination of education and experience
• Progressively responsible experience in regulatory affairs, clinical research project management, and staff supervision
• Demonstrated ability to independently manage assigned studies and regulatory work, coordinate multiple stakeholders, and supervise, train, and evaluate staff
• Demonstrated knowledge of IRB processes, human research protection requirements, Good Clinical Practice, and regulatory documentation
• Strong written and verbal communication, planning, organization, problem solving, attention to detail, and follow-through
• Ability to manage competing priorities, anticipate and resolve study-related problems, maintain study quality, and meet deadlines
• Proficiency with standard office, collaboration, and research-tracking tools

Preferred

• Experience in academic clinical research, SOP development, staff training, process improvement, and electronic regulatory document systems
• A relevant master's degree or research/regulatory certification
• IND/IDE submission experience when relevant to assigned services
• Experience communicating research services and developing collaborations

Pay

Annual salary range: $91,066.00 – $106,940.00. Offers are based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance; flexible spending accounts for eligible health care and dependent care expenses
• Tuition assistance for employee, spouse, and dependent children at Penn; dependent children also eligible for tuition assistance at other institutions
• Generous retirement plans (Basic, Matching, and Supplemental) with pre-tax or Roth options; investment options through TIAA and Vanguard
• Substantial time away from work (vacation, personal, sick, holidays)
• Long-term care insurance through Genworth Financial (no proof of good health required if enrolled when newly hired)
• Wellness and work-life resources
• Professional and personal development resources
• Access to University libraries, athletic facilities, arboretum, art galleries, museums, and cultural events (many free or discounted)
• Discounts on arts/entertainment, transportation, mortgages, cellular plans, movie tickets, theme parks, and vehicle purchases
• Flexible work options (non-traditional hours, locations, and/or job structures)
• Penn Home Ownership Services: forgivable loan for eligible employees buying a home or residing in West Philadelphia (closing costs or home improvements)
• Adoption assistance: reimbursement for qualified expenses up to two adoptions per household

Background checks may be required after a conditional job offer; consideration will be tailored to the requirements of the job.